CardioExchange Archive

The FDA’s Circulatory System Devices advisory panel voted unanimously on Thursday to support approval of CR Bard’s Lutonix Drug-Coated Balloon (DCB). It would be used to enlarge arteries in a subset of patients who have peripheral arterial disease — including obstructive de novo or nonstented restenotic lesions (≤ 15 cm in length) in native femoropopliteal arteries with reference vessel diameters of 4 mm to 6 mm.

The PreMarket Approval (PMA) application is based on the pivotal Levant 2 trial in which patients were randomized to the DCB or standard percutaneous transluminal angioplasty. The trial was successful in demonstrating both the safety and efficacy of the DCB. At one year the primary efficacy endpoint — freedom from target lesion restenosis and target lesion revascularization — was significantly higher with the DCB (65.2% versus 52.6%).

However, the advisory panel spent much of the day trying to interpret the complexities of the trial. There were a large number of protocol violations in the control arm, so that the results were no longer significant in the per protocol analysis. In addition, the DCB did not benefit women in the trial and the DCB was more effective in sites outside the U.S. than in the U.S. sites.

“We really had a hard time,” said panel member Rick Lange. “It looked like in the non-U.S. sites there was a clear advantage, but in the U.S. sites it was marginal, while in females it didn’t look like it was good.” Panel members had to decide whether to lump the data or split it. “We decided to lump it together,” said Lange.

The unanimous vote, said Lange, was a reflection of the committee’s view that the device was both safe and at least as effective as PTA. “It’s a little easier than a stent since you’re not leaving anything inside,” he said.

The panel urged the FDA to require the sponsor to provide long-term data for the DCB, including a post-approval study and continued followup of current patients. They said the outcomes study should be large enough to study men versus women and U.S. versus non-U.S..

If it is approved, Lutonix would become the first DCB available in the U.S. A second DCB from Medtronic is thought to be about six months behind Lutonix in the approval process.